MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD IN LINE PRECISION VAVLE SG H; PRECISION VALVES WITH SG

Catalog Number	825465
Medical Device Problem Codes	Use of Device Problem (1670); Illegible Information (4050)
Health Effect - Clinical Code	Lethargy (2560)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported: "a 5-year-old patient underwent shunt revision on (b)(6) 2024 for radiological and clinical shunt failure.Uneventful procedure and recovered well over the following days.Clinical deterioration on (b)(6) 2024 and scan demonstrated ventricles enlarged.Therefore, went for another shunt exploration which demonstrated a non-functioning valve which was a fixed high-pressure valve with antisiphon, as opposed to a fixed medium-low pressure valve with antisiphon.Therefore, the wrong valve was inserted in the first shunt revision and the patient required a further procedure to correct this." "there was nothing wrong with the implant, but the wrong implant was inserted.It is not felt to have been directly causative of this error, but the labelling on the packaging that identifies the type of shunt and its properties is in very small print." additional information: - which reference/type of valve was supposed to be implanted initially? "833283 medium -low pressure".- it was mentioned clinical deterioration on (b)(6) 2024 and scan demonstrated ventricles enlarged.What are the consequences/symptoms for patient health? "lethargy (in a patient with already reduced consciousness level compared to pre-tumour removal), possibly headaches." - can you please confirm that this clinical deterioration is directly caused by the fact that the wrong type of valve was implanted? "yes." - was another valve implanted instead? which reference? "(b)(4) high pressure with siphonguard." - what is the current status of the patient, after the revision? improved after the operation.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The precision valve was not returned for evaluation (is not available for return as per customer); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, based on additional information provided by the costumer, the root cause is due to the wrong product implanted (human error).If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: IN LINE PRECISION VAVLE SG H
• Common Device Name: PRECISION VALVES WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22978141
• Report Number: 3013886523-2025-00239
• Device Sequence Number: 15810015
• Product Code: JXG
• UDI-Device Identifier: 10381780535201
• UDI-Public: (01)10381780535201(17)280531(10)7267572
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 825465
• Device Lot Number: 7267572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Unknown